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Search results for: Software Development

What complying with ISO 13485 means for medical software development – and for us

As a software development company, we don’t necessarily need to be compliant with external quality standards, but we want to be. And ISO 13485 certification is especially important in the context of medical app development – even more so with the Medical Device Regulation (MDR) becoming fully applicable in May 2021. If what you’re doing is related to healthcare, biotech, pharma, or digital health in general, you should definitely take this topic seriously. Read on to find out why ISO compliance is important in the medtech software development process.

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HL7 FHIR: Foundations in the architectural context

The Fast Healthcare Interoperability Resources (HL7 FHIR) standard describes how healthcare information can be exchanged between different computer systems. Seeing how already some 30% of the world’s data is generated by the healthcare industry – and a lot of it is highly sensitive – it’s no wonder this standard came into existence. Let me try to explain why it’s important and how it works from a software developer’s perspective.

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Medical Device Regulation (MDR) and its consequences for healthcare software development

Innovating in the healthcare industry means working on improving people’s lives through technology. But it also means having to adhere to regulations that ensure the solutions you create are safe for the patients – in many different ways. Medical Device Regulation (MDR) is probably the most important set of rules you need to follow when building a medical app. Let’s dive into why it exists, what it means for the healthtech sector, and why you should get familiar with it – especially if you’re planning to launch your medical app in Europe.

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How to improve communication between bioinformaticians and engineers in biotech software development

Biotechnological companies are full of amazing specialists who create the future of healthcare. They often have a strong team of bioinformaticians that combine IT, medical, biological, and other specialized know-how. They are responsible for the gathering, analysis, and visualisation of data, as well as prototyping and creating initial versions of the product. That doesn’t necessarily mean they are software engineers and should be tasked with developing a complete, scalable system that’s based on a prototype they created. It’s often best for the “general-purpose” software engineers to take over the project, stabilize it, deploy it and maintain it.

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